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Brachial Artery t-PA Release in Heart Transplant Recipients (P1A3C)

This study has been withdrawn prior to enrollment.
(Bradykinin Shortage, SCCOR expired prior to BK availability, lack of enrollment.)
Information provided by (Responsible Party):
James Muldowney, Vanderbilt University Identifier:
First received: October 24, 2008
Last updated: July 14, 2016
Last verified: July 2016

Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in culture. It has been proposed that the nerves of blood vessels are the source of bradykinin stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin into the brachial (arm) artery and the coronary arteries of heart transplant recipients and control subjects. This is because heart transplant recipients do not have nerves to their coronary arteries.

This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant recipients. The brachial artery has intact nerves.

Separate protocols address coronary artery infusions in healthy subjects and transplant recipients and forearm infusions in healthy subjects.

Condition Intervention
Heart Transplantation
Drug: Bradykinin

Vanderbilt University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Characterization of Brachial Arterial t-PA Release, Vasodilator Function, and Vascular Compliance and Correlation With Fibrinolytic Balance, Oxidative Stress, and Inflammation Measures in Heart Transplant Recipients (SCCOR Project 1, Aim 3C)

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Peak t-PA release [ Time Frame: Single Study Visit ]

Secondary Outcome Measures:
  • t-PA release at various doses [ Time Frame: Single Study Visit ]

Enrollment: 0
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bradykinin
Patients receive 0, 10, 20, and 40 ng/min/100cc forearm volume of intrabrachial bradykinin, for 5 minutes at each dose. Forearm blood flow will be measured by strain gauge plethysmography, blood samples will be obtained to measure t-PA, PAI-1 at each dose. FMD and Radial artery tonometry will also be performed under resting conditions.
Drug: Bradykinin
Patients receive 0, 10, 20, and 40 ng/100cc forearm volume/min of bradykinin intrabrachial.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Adults 18 years and greater who have undergone heart transplantation
  2. Healthy

Exclusion criteria:

  1. PVC < 30
  2. Hypertensive subjects on ACE inhibitors
  3. Pregnant or nursing mothers
  4. Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
  5. Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
  6. Triglycerides > 200
  7. Previously diagnosed obstructive coronary artery disease
  8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
  9. History of cerebrovascular disease
  10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
  11. Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
  12. Angiotensin converting enzyme inhibitor use
  13. Coagulopathy (INR ≥ 1.5, PTT ≥ 150% of control)
  14. Peripheral Vascular Disease
  15. Other chronic medical illnesses at the discretion of the investigators
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Please refer to this study by its identifier: NCT00780637

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: James AS Muldowney, MD Vanderbilt University Medical Center
  More Information

Responsible Party: James Muldowney, Assistant Professor of Medicine, Vanderbilt University Identifier: NCT00780637     History of Changes
Other Study ID Numbers: 070517
Study First Received: October 24, 2008
Last Updated: July 14, 2016

Keywords provided by Vanderbilt University:
Heart Transplant
Endothelial Function
Transplant recipients at baseline

Additional relevant MeSH terms:
Vasodilator Agents
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017